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Completed

NCT Number: NCT00750620

A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment

The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good health other than renal impairment
  • body mass index (BMI) between 18 and 40 kg/m2

Exclusion criteria

  • subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
  • subject has liver enzyme abnormalities

Treatment and study plan

YM178

Drug

oral

Other names: mirabegron

Primary outcomes

  1. Assessment of pharmacokinetics parameters

    Time frame: day 1 - day 6

Secondary outcomes

  1. Metabolite analysis

    Time frame: day 1 - day 6

  2. Assessment of safety and tolerability

    Time frame: day 1 - day 6

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2008
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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